(pp) Studies, Tests and Preclinical and Clinical Trials. The studies, tests and
preclinical and clinical trials conducted by or, to the Companys knowledge, on behalf of the Company or any of its subsidiaries, that are disclosed in the General Disclosure Package, and are intended to be or have been submitted to the FDA or
other comparable governmental entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls, applicable authorizations and laws, including, without limitation,
the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and, for studies submitted to regulatory authorities for approval, in all material respects, current Good Clinical Practices and Good Laboratory Practices
and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted, in all material respects; the descriptions of the results of such studies and trials contained in the General Disclosure Package are,
to the Companys knowledge, accurate and complete and fairly present the data derived from such studies and trials in all material respects; except to the extent disclosed in the General Disclosure Package, the Company and each of its
subsidiaries, is not aware of any studies, tests or trials, the results of which the Company believes materially call into question the study or trial results described or referred to in the General Disclosure Package when viewed in the context in
which such results are described and the clinical stage of development; and, except to the extent disclosed in the General Disclosure Package, the Company or any of its subsidiaries have not received any written notices or correspondence from the
FDA or any governmental entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or any of its subsidiaries, other than ordinary course communications with
respect to modifications in connection with the design and implementation of such studies, tests or trials, copies of which communications have been made available to you.
(qq) Compliance with Health Care Laws. The Company and its subsidiaries are, and at all times have been, in compliance with all
applicable Health Care Laws and to the extent applicable to the Companys current business and product candidates, except to the extent that any non-compliance would not have a Material Adverse Effect.
For purposes of this Agreement, Health Care Laws means: (i) the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act (42 U.S.C. §§ 201 et seq.); (ii) all applicable federal, state, local and foreign
health care fraud and abuse laws; (iii) the Health Insurance Portability and Accountability Act (HIPAA), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.);
(iv) applicable licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; (v) all other applicable local, state, federal, national, supranational and foreign laws,
relating to the regulation of the Companys current business and product candidates; and (vi) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S.
counterpart thereof. To the Companys knowledge, neither the Company nor any of its subsidiaries, nor any of its respective officers, directors, employees or agents have engaged in activities which materially violate a Health Care Law. Except
as disclosed in the General Disclosure Package, neither the Company nor any of its subsidiaries have received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or
arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Companys knowledge, is any such claim, action, suit, proceeding, hearing,
enforcement, investigation, arbitration or other action threatened, except in each case as would not, individually or in the aggregate, have a Material Adverse Effect. The Company and its subsidiaries have filed, maintained or submitted all material
reports, documents, forms, notices, applications, records, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, submissions and supplements or
amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission), except where such failure would not have a Material Adverse Effect. Neither the Company nor any of its
subsidiaries, nor, to the knowledge of the Company, any of its respective employees, officers, directors, or agents is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements
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